Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty

Anemia Clinical Trial

Official title:

Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty - A Descriptive Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02385409
• Other study ID #: RH-4074-OJ5
• Status: Active, not recruiting
• Phase: N/A
• First received: February 16, 2015
• Last updated: March 5, 2015
• Start date: May 2013
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.

Treatment of preoperative anemia is recommended. However the type of preoperative anemias in elective hip- and knee surgery has only been sparsely studied.

This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.

Description:

Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.

In elective orthopedic surgery, international guidelines recommends treatment of preoperative anemia including the use of Iron supplements for anemias associated with iron deficiency. In addition, low iron stores in both anemic and non-anemic patients may delay postoperative hemoglobin recovery.

However, the reasons for preoperative anemia and the prevalence of patients with low iron stores have only been sparsely studied in elective hip- and knee arthroplasty.

This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Scheduled for elective primary hip- or knee replacement.

Exclusion Criteria:

• Not possible to obtain preoperative blood sample.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, Department of orthopaedic surgery	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Oeivind Jans	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia Classification - Biochemical classification from preoperative venous blood samples	Biochemical classification from preoperative venous blood samples	Date of preoperative blood sampling	No
Secondary	Prevalence of Anemia according to WHO definitions	According to WHO definitions	Date of preoperative blood sampling	No
Secondary	Proportions of non-anemic patients with low irons stores	Low Ferritin or Transferin saturation (TSAT)	Date of preoperative blood sampling	No